Good Clinical Practice (GCP)

URI: https://gptkb.org/entity/Good_Clinical_Practice_(GCP)
GPTKB entity
Statements (47)
Predicate Object
gptkbp:instanceOf gptkb:Tourism
gptkbp:abbreviation gptkb:GCP
gptkbp:adoptedBy gptkb:U.S._Food_and_Drug_Administration_(FDA)
gptkb:European_Medicines_Agency_(EMA)
gptkb:Pharmaceuticals_and_Medical_Devices_Agency_(PMDA)
gptkbp:appliesTo clinical trials involving human subjects
biological product clinical trials
medical device clinical trials
multinational clinical trials
pharmaceutical clinical trials
gptkbp:basisFor clinical trial approval
regulatory inspections
gptkbp:category gptkb:medical_guideline
clinical trial regulation
gptkbp:developedBy gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use_(ICH)
gptkbp:enforcedBy regulatory authorities
gptkbp:field clinical research
gptkbp:firstPublished 1996
gptkbp:focusesOn credibility of clinical trial data
rights, safety, and well-being of trial subjects
gptkbp:ICHGuidelineNumber E6
gptkbp:includes informed consent
auditing
data integrity
monitoring
protocol adherence
investigator responsibilities
sponsor responsibilities
gptkbp:language English
gptkbp:purpose ensure ethical and scientific quality of clinical trials
gptkbp:referencedIn gptkb:EMA_guidelines
gptkb:FDA_21_CFR_Part_312
gptkb:WHO_guidelines
gptkbp:relatedTo gptkb:Belmont_Report
gptkb:Declaration_of_Helsinki
gptkbp:requires gptkb:manual
quality assurance
adverse event reporting
risk management
confidentiality
ethics committee approval
qualified investigators
gptkbp:trainingRequiredFor clinical research professionals
gptkbp:updated periodically
gptkbp:bfsParent gptkb:FDA_Guidelines
gptkbp:bfsLayer 6
https://www.w3.org/2000/01/rdf-schema#label Good Clinical Practice (GCP)